Study of Denufosol Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-09-30

Brief Summary

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The purpose of this trial is to evaluate the safety and effectiveness of a one dose strength of denufosol compared to placebo in patients with mild CF lung disease.

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Placebo

Group Type PLACEBO_COMPARATOR

Placebo - 0.9% w/v sodium chloride solution

Intervention Type DRUG

4.2 mL of solution, allowing delivery of approximately 4 mL into the nebulizer cup for nebulization, three times daily for six months.

2

Group Type EXPERIMENTAL

denufosol tetrasodium (INS37217) Inhalation Solution

Intervention Type DRUG

Denufosol 60 mg is administered as an inhalation solution, three times daily for six months during the double-blind portion of the study. Subsequently, denufosol 60 mg is administered for an additional six months during the open label safety extension.

Interventions

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denufosol tetrasodium (INS37217) Inhalation Solution

Denufosol 60 mg is administered as an inhalation solution, three times daily for six months during the double-blind portion of the study. Subsequently, denufosol 60 mg is administered for an additional six months during the open label safety extension.

Intervention Type DRUG

Placebo - 0.9% w/v sodium chloride solution

4.2 mL of solution, allowing delivery of approximately 4 mL into the nebulizer cup for nebulization, three times daily for six months.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have confirmed diagnosis of cystic fibrosis
* Have FEV1 of greater than or equal to 75% of predicted normal for age, gender, and height
* Be able to reproducibly perform spirometry maneuvers
* Be clinically stable for at least 4 weeks prior to screening

Exclusion Criteria

* Have abnormal renal or liver function
* Have chest x-ray at screening suggesting clinically significant active pulmonary disease
* Be colonized with Burkholderia cepacia
* Have had a lung transplant

Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No